Fiberoptic Components (FOC) offers our OEM customers disposable, single-use, fiber optic cables as either Class I or Class II devices. Acting as a complete solutions provider, FOC provides a service to meet each client’s product specification–by working hand-in-hand with the client’s product development and engineering design team, and alleviating pressures throughout the production process – from design and validation through manufacturing and final packaging.
FOC has delivered thousands of disposable cables per ISO 13485:2003 and developed a reputation as a consistent product quality and on time delivery supplier.
Leveraging our ISO Certified, vertically-integrated facilities in Sterling, MA, we are able to provide your single-use medical fiber optic product as a turnkey ready-to-ship solution, by offering:
- Validation Testing
- Bioburden Testing and Reporting
- Biocompatibility Testing and Reporting
- Cleaning Log
- Packaging Reporting including Seal Strength Testing
- Certificate of Sterilization Processing including Sterility Report
- HIBIC & GS1 & UDI Bar Code Labeling
- Certificate of Compliance
In addition, various kanban programs are available to meet our customers’ fulfillment requirements once product deliveries begin.
Should our customer prefer to perform their own packaging and sterilization protocol, Fiberoptic Components also offers a designed disposable product based on client product specifications.
For more information about how Fiberoptic Components can solve your disposable cable requirements please contact us.